JP2016525391A - Surgical training and imaging brain phantom - Google Patents

Abstract

A brain phantom including a living sulcus and an anatomically correct structure is disclosed. Phantoms are made of materials that mimic one or both of the biomechanics and imaging properties of the human brain. The phantom may be a single phantom or a kit including a biomechanical phantom and a separate imaging phantom. The imaging phantom includes a structure that mimics the white tract or bundle of the brain that can be observed using DTI, and allows the above imaging techniques to be practiced in addition to performing physician surgical techniques Can include post-production DTI images. [Selection] Figure 5

Description

(Cross-reference of related applications)
This application claims priority to US Provisional Patent Application No. 61 / 845,256, filed July 11, 2013, entitled “SURGICAL TRAINING AND IMAGING BRAIN PHANTOM,” the entire contents of which are incorporated herein by reference. Incorporated into.
This application also claims priority to US Provisional Patent Application No. 61 / 900,122 entitled “SURGICAL TRAINING AND IMAGING BRAIN PHANTOM” filed on November 5, 2013, the entire contents of which are hereby incorporated by reference. Embedded in the book.

The present invention relates to a model of a mammalian head and brain. More particularly, the present disclosure relates to mammalian head and brain models and phantoms for training such as invasive surgical procedures, image modalities and medical procedure simulations.

In the medical field, imaging and image guidance tend to become important elements of clinical practice. From disease diagnosis and monitoring to surgical approach planning, guidance during treatment and follow-up after treatment is complete, imaging and image guidance are effective and multifaceted for a variety of treatments, including surgery and radiation therapy A new therapeutic approach.
Targeted stem cell delivery, adaptive chemotherapy regimens, and radiation therapy are just a few examples of treatments utilizing imaging guidance in the medical field.

  Advanced imaging modalities such as magnetic resonance imaging (“MRI”) perform imaging of diseases such as brain tumors, strokes, intracerebral hemorrhage (“ICH”), and neurodegenerative disorders such as Parkinson's disease and Alzheimer's disease Has led to improvements in the speed and accuracy of detection, diagnosis and staging in several medical fields, including neurology. As an imaging technique, MRI tends to allow three-dimensional visualization of tissue with high contrast in soft tissue without using ionizing radiation. This modality uses ultrasound (“US”), positron emission tomography (“PET”), and computed X-ray tomography by examining the same tissue using the different physical principles available for each modality. Often used in conjunction with other modalities such as law ("CT").

  CT is often used in conjunction with intravenous injections such as iodine contrast agents to visualize bone structure and blood vessels. MRI can also be performed using similar contrast agents such as intravenous gadolinium contrast agents with pharmacokinetics that allow visualization of tumors and blood brain barrier breakdown.

  These multi-modality solutions can provide varying degrees of contrast between different tissue types, tissue functions, and medical conditions. Imaging modalities can be used separately or in combination to better differentiate and diagnose disease.

  For example, in neurosurgery, brain tumors are typically resected through craniotomy guided by imaging. The data collected in these solutions typically consists of a CT scan with an associated contrast agent such as an iodine contrast agent and an MRI scan with an associated contrast agent such as a gadolinium contrast agent. . Optical imaging is also often used in the form of a microscope, known as the margin, to distinguish tumor boundaries from healthy tissue. Instrument tracking for the patient and associated imaging data is also often accomplished by an external hardware system, such as a mechanical arm, or a high frequency or optical tracking device. Collectively, these devices are commonly referred to as surgical guidance systems.

Because image-guided surgical procedures are inherently complex and the risks associated with the use of such procedures in the brain are high, surgical staff often have simulated rehearsals of the entire procedure. Need to rely on to do. Unfortunately, the tools and models currently available for simulated rehearsals and training exercises cannot provide sufficiently accurate simulations.

In one aspect of the invention, a head phantom kit is provided, wherein the phantom is
a) a first imaging head phantom composed of a material selected on the basis of being imageable by at least one imaging technique and comprising an anatomical mimic of a mammalian brain;
b) at least one (second) biomechanical head phantom composed of one or more materials that mimic the biomechanical properties of the mammalian head;
c) A first imaging head phantom, said the at least second biomechanical phantom, is registered together to provide navigation of the second biomechanical head phantom during a surgical training procedure One or more images acquired from the imaging head phantom are copied to a second biomechanical head phantom, which includes a system in which the image geometry and features are correctly correlated.

Also provided is a method of manufacturing a brain phantom with a deep sulcus, imitating the deep sulcus of the brain using the method of acquiring an image of the human brain and imaging the human brain described above, Create an anatomically accurate model by 3D printing and apply a flexible formwork material to the outer surface of the brain model to release the brain mold from the brain model after the mold material becomes a brain mold And placing a brain mold on a hard outer shell, pouring material into the frame that mimics the brain's liquid precursors, and optionally mimicking one or more of the brain's structural features Implanting the liquid precursor, solidifying the liquid precursor to form an anatomically accurate deep sulfur brain phantom, and releasing the brain phantom from the brain mold.

Also provided is a mammalian brain phantom, which is a simulated mammalian brain containing the topographical structure of the sulci, and the simulated mammalian brain composition is one or more structural features by imaging techniques Are recognizable and have one or more biomechanical properties that are comparable to one or more relevant biomechanical properties of the actual mammalian brain.

Embodiments will now be described by way of example only with reference to the drawings.
FIG. 1 is an illustration of an example port-based surgical approach. The port is inserted along the sulcus approaching a tumor located deep in the brain. FIG. 2 is an explanatory diagram of a learning model as an example of an exploded view showing a base component and a learning component. FIG. 3 is a diagram illustrating a base component of an example of a learning model showing a tray, a head, and a skull. FIG. 4 is a diagram showing important reference points for registering images acquired using different modalities, and showing the base components of an example of a skullless learning model. FIG. 5 is a diagram illustrating a base component of an example of a learning model including a learning component. FIG. 6 is a diagram illustrating various clinically relevant example components that can be emulated in a model, and a detailed view of an example example learning component. FIG. 7 is an image showing an example model of a mammalian brain included in an example learning component. This model shows the sulcus and cerebral lobe. FIG. 8A is a photograph of a learning model in which a learning model that explains the foundation components and the brain components is implemented. Facial features are not shown in this example base component. FIG. 8B is a photograph of a learning model in which a learning model that explains the foundation components and brain components is implemented. This example base component does not show facial features. FIG. 9 is a view showing the display of the MR image of the brain phantom, showing the surface structure (brain groove), the visibility of the implanted target tumor and the reference point. FIG. 10 is a CT image showing a brain region and an implanted tumor using the learning model. FIG. 11 is a diagram showing 3D reconstruction of a CT image and showing a reference marker, a reference point, and a surface structure (brain groove). FIG. 12 shows the use of MR images acquired at the time of manufacture (left side of the figure) for iteratively fine-tuned data collection protocols and parameters. Improvement is achieved using effective measures or metrics. FIG. 13 is a photograph showing an image of a brain phantom manufactured according to the method disclosed herein. FIG. 14 is a diagram showing a diffusion image acquired by MRI in which the grid is reconstruction of the fiber tube in the image.

Various embodiments and aspects of the invention are described in detail below. The following description and drawings are illustrative of the disclosure and should not be construed as limiting the invention. Numerous detailed descriptions are provided to assist in understanding the embodiments of the present invention. In some examples, well-known or conventional technical contents are omitted, and embodiments of the present invention are briefly discussed.

Expressions such as “comprising”, “including”, and “having” described in this specification are inclusive, do not impose any limitation, and are not used as exclusive expressions. Specifically, as used herein and in the claims, “comprising”, “including”, “having” and variations thereof are meant to encompass the features, steps, or components identified therein. These representations should not be construed as excluding other features, steps, or components.

Expressions such as “example”, “exemplary”, “for example”, “etc.” described herein should not be construed as preferred or useful over other configurations described herein.

Expressions such as “about”, “abbreviated”, and “approximately” described in this specification include numerical values within the upper and lower limits of the numerical value range in characteristics, parameters, dimensions, and the like. In one example, expressions such as “about”, “substantially”, and “almost” mean plus / minus of 10% or less, but are not limited thereto.

When performing neurosurgery and / or diagnostic procedures, minimally invasive procedures and neurosurgical techniques such as craniotomy or nasal surgery or port-based surgical methods may be performed to provide access to the brain . In such surgery, the medical procedure must invade the mammalian head. For example, as shown in FIG. 1, in a port-based surgical method, the port (100) moves deeper along the sulcus (110) of the brain (120) to access the tumor (130). Inserted into.

According to the embodiments provided herein, simulation of such a procedure can be accomplished by providing a brain model suitable for simulating surgery through one or more layers of the head. it can. Such procedures can be drilled, stamped, perforated, as appropriate, for nasal endoscopes, port-based, or conventional craniotomy approaches. For example, some embodiments of the present disclosure provide a brain model that includes an artificial skull layer suitable for simulating a process of penetrating a mammalian skull. As described in more detail below, once the skull layer is penetrated, the medical procedure simulated using the learning model may include additional steps in the diagnosis and / or treatment of various medical conditions. Such conditions may relate to normally occurring structures, abnormal structures, and / or anatomical features that are implanted under the skull.

In some embodiments, the brain model is suitable for simulating a medical procedure involving a brain tumor selected for resection. In such exemplary embodiments, the brain model is composed of a material having a brain tumor simulated therein. This brain material simulates or mimics at least a portion of the brain to which a medical procedure is directed or focused.

The medical procedure simulation described above is accomplished by pre-surgical (pre-operative image), surgical (intra-operative image) and related imaging steps performed between them. Pre-operative imaging simulations are used to train surgical teams for simultaneous registration by multiple imaging methods such as MR, CT and PET, for example. Appropriate co-registration is geometrically useful during the surgical planning stage. It is advantageous if the images from different modalities are aligned, the affected area in the human body is identified, and an appropriate path to access the affected area is selected. Another use for preoperative images is to train surgical teams and radiologists to optimize imaging parameters so that clinically relevant images are acquired prior to the surgical procedure. For example, pre-operative MR images are generated in a specific way to generate tractographic information such as diffusion tensor imaging (DTI) that shows the position and orientation of the invisible brain track. Need to get. Where intraoperative imaging is possible, it is used to guide the surgeon through precise surgical intervention while avoiding damage to the brain track. Surgical intervention involves accessing an affected area previously identified in the human body and excising the affected tissue.

FIG. 2-6 is an exploded view of a model or phantom as a general example at (100), which is suitable for use in training or simulation of an invasive medical procedure in a mammalian head. The learning model (100) may be designed to fit or simulate any mammalian head or part thereof. The trained subjects are doctors, residents, students, researchers, equipment technicians, specialists, personnel, etc. In other embodiments, the models provided herein can be used in simulations involving the use of automated devices as robotic surgery and / or diagnostic systems.

As shown in the exploded view of the embodiment of FIG. 2, the learning model (100) includes a base component and a learning component. The base component is composed of a tray component (200) and a head member. The head member is composed of a bowl member (210) and a skull member (220). The learning component may be composed of layers of the brain (230) such as the dura mater, CSF (cerebrospinal fluid), blood vessels, white matter, gray matter, fiber bundles or tracks, target tumors, or other abnormal structures. When crafted with a skull mimetic, the learning component may include the skull member (220). If desired, the learning model (100) can be covered with a skin layer (not shown). Further, the foundation component may include a holder (240) provided on the tray (200) to facilitate navigation reference points or easy attachment of the reference points.
In FIG. 3-5, the tray member (200) forming part of the foundation component is a training receptacle, including a pedestal (242) configured to receive the bowl member (210) therein. . Thus, the learning component (100) is specifically tailored to the size of the foundation component so that the training receptacle is complementary and easily assembled with the foundation component.

The foundation component has the appropriate size or shape or configuration to support the learning component in an appropriate setting for performing a medical procedure. This base component has functions that can be registered as 3D surface scan, MR, CT, OCT, US, PET, reference points for optical registration and face registration, touch point positions, and face contours. The foundation component is also configured to set the learning component at a relatively stable or fixed position throughout the execution of the medical procedure while simulating the training procedure. The foundation component supports the learning component in the proper orientation and provides mechanical support to mimic the actual position of the patient's head during surgery.

In FIG. 2 and FIG. 3 described above, the base component is composed of a head component (210) and a tray component (200). The tray component (200) is adapted to be sized, compatible, or complementary to the head component (210). The tray component (200) is configured to maintain the head component (210) in a stable or fixed position during a medical or imaging procedure. This may employ mechanical features such as a snap mechanism to secure the tray component (200) and the head member (210). The tray component (200) may include a groove (244) for capturing liquid and an insertion point for securing tools used in image registration and / or training medical procedures.

The head component (210) is adapted to be sized, compatible, or complementary to the tray part (200). The head component (210) is configured to maintain the learning component (230) (located below the skull member 300) in a stable or fixed position when simulating a medical procedure. The head member (210) is configured to allow anatomically accurate surgical placement. It is fitted with a head component (210) and a surgical skull clamp or headrest and secured with, for example, a Mayfield skull clamp. This head member (210) enables an anatomically accurate imaging position, such as MR, CT, OCT, US, PET, optical registration, face registration, and the like. For example, the head component (210) is placed in a supine position within the MRI apparatus to allow anatomically accurate coronal images to be acquired.

In some embodiments, the head component (210) is shaped or configured to simulate a complete skull. In other words, the learning component includes a bowl portion (210) and a skull portion (220), and the bowl portion (210) further includes a complete skull and head portion. As shown in FIG. 2, in some embodiments, the head member, ie, the bowl member (210), the skull member (220), and the training member (230) are combined to provide a complete simulated skull. Including the skull (220) and brain (230) together. The simulated head provided by the learning model (100) enhances the reality of the overall simulation training experience.

Also, as shown in FIG. 4, the foundation and learning components (especially head components) of the learning model (100) include one or more external anatomical landmarks or reference locations (400). For example, it is a position for registering images for a touch point, a track surface, a nasal bone, a central turbinate, a lower turbinate, a occipital bone, a nape, and a nasal cavity. These functions help to combine learning components with preoperative images such as MR, CT, OCT, US, and PET so that surgical instruments can be navigated properly.

In this regard, navigation to locate the hole or passage in the patient's skull during craniotomy is often important for successful medical procedures. Thus, external anatomical landmarks and / or touch points are provided by the simulated head to provide training for correct registration of the learning model. These anatomical landmarks and touch points are used, for example, to attach a registration tool with a face registration mask or reference landmark. In this way, the learning model, in particular the simulated head, is sized to resemble the size, configuration and shape of the patient's head on which the medical procedure is performed closely with the approximation. In other words, the head component can be both “living” and “life-sized”.

The foundation component can be composed of any composition or material suitable to support the learning component receptacle and can be cast, molded, or otherwise constructed. For example, the base component may be composed of any suitable casting compound with a composition or gypsum. The foundation component may be constructed of a material that is non-ferrous, non-reflective, rigid, non-porous, washable, and lightweight. For example, it is composed of urethane or ABS resin. Also, the base component bowl (210) and skull (220) may be composed of the material being displayed by the imaging procedure to allow registration. Thus, the material of the base component bowl (210) and skull (220) may be selected to be visible by MR, CT, and / or PET. Various properties suitable for mimicking a skull member (220) tailored to the imaging modality are shown in Tables 1, 2 and 3.

In another embodiment, the foundation component may be manufactured from materials that do not appear on the MR, CT, and PET. It is especially valuable if the scope of training does not include facial registration and craniotomy. For example, it is widely known that the foundation component can select Teflon when it needs to be transparent on MRI. This eliminates subsequent software processing steps that require the skull structure to be removed in the brain image. This step is commonly known as skull stripping, which is quite computationally expensive.

The three simulation procedures described above (ie, preoperative imaging simulation, surgical simulation, and intraoperative imaging simulation) can be implemented using a model or phantom that shares some common characteristics. The properties of materials that mimic tissue that are suitable for imaging are presented as follows.

PET images require injection of a radioactive contrast agent before imaging. The half-life of the contrast agent limits the useful life of the training phantom. To prevent this, the contrast agent can be made by manufacturing a phantom with a microcapillary so that it can be introduced through the capillary just prior to PET imaging. Alternatively, contrast agents can be injected into selected areas of the brain components.

Density to mimic the brain with CT and US images
The preferred brain physical properties for CT and US imaging are shown in Table 1 (Barber, Ted W., Judith A. Brockway, and Lawrence S. Higgins. "The Density Of Tissues In And About The Head." Acta Neurologies Scandinavica 46.1 (1 970): 85-92. Web.).
Table 1: Properties suitable for CT and US imaging

Optical properties for mimicking brain with OCT imaging are shown in Table 2 (Cheong,
Wf, Sa Prahl, and Aj Welch. "A Review of the Optical Properties of Biological Tissues." IEEE Journal of Quantum Electronics 26.12 (1990): 2166-185. Web.).

Table 2: Preferred brain properties for OCT imaging or material properties suitable for mimicking intraoperative ultrasound (I-US) are established using the operating frequency of a typical ultrasound transducer. (Reference: http://www.bkmed.com/lntraoperative_US_en.htm)

For intraoperative US, the frequency range is 4 to 10 MHz. This is based on equipment such as the BK medical transducer, intraoperative 8815, T-shaped intraoperative 8816, intraoperative biplane 8814, 8809 hockey stick, and intraoperative biplane 8824. The average propagation velocity through the mixed tissue at 5 MHz is 1565 m / s. Another characteristic of tissue that is preferred for ultrasound imaging is the attenuation coefficient. This is shown in Table 3. (Kremkau, Frederick W. "Ultrasonic Attenuation and Propagation Speed in Normal Human Brain." The Journal of the Acoustical Society of AmericalO .1 (1 981): 29. Web.)
Table 3: Attenuation factors for ultrasound at 5MHz frequency through the brain

The brain tissue parameters essential for mimicking MR images are T1, T2, and spin density. This is shown in Table 4 for the various components of the brain.
Table 4: T1, T2, and spin density in different parts of the brain

Finally, PS-OCT is used to visualize the birefringent properties of living tissue. Birefringence depends on directionality and will vary quantitatively depending on the brain being imaged. However, by using certain materials, visually invisible brain tracts can be optimally organized.

In FIG. 5, the learning component (230) and the base component (210) are complementary or interchangeable, and then once the learning component (230) is mounted on the tray (200) of the pedestal (242), together They become learning models. The configurations and dimensions of the learning component (230) and the base component (210) are matched to each other. The base component (210) then receives the learning component (230) so that it can be mounted fixedly or released.

In some embodiments, the learning component is removable or releasable and attached to the base component (210) to allow replacement or replacement of the learning component (230). Any removable or releasable fastener or fastening mechanism may be used to attach the learning component (230). It can be easily removed or released or deleted as needed. In one embodiment, the learning component (230) is attached to a releasable or removable and retained in the base component (210) to emulate the mechanical fixation of the brain within the skull.

As described above, in the present embodiment example, the learning component (230) may be removed from the base component (210) and replaced with an alternative or replacement learning component as necessary. For example, if the learning component (230) breaks during training, a replacement learning component (230) may be required. The alternative learning component (230) may be adapted for training to suit a particular medical procedure or patient condition and may then be reusable with the base component (210).

Moreover, as shown, the learning model (100) may not include the foundation component (210). In this example, other members including the learning component (230) (eg, the learning model (100)) may be provided standalone and support a support structure (not shown) that does not look like a mammalian head. It may be supported directly by the mechanism. Specifically, the support structure can maintain the learning component (230) firmly in the desired orientation and without other components of the learning model. In such embodiments, once the user of the learning model is removed from the support structure of the learning component (230) as desired or necessary, it can be replaced with an alternative alternative learning component (230).

In FIG. 6, the learning component (230) may be composed of a simulated mammalian head. Simulated heads are skull (220), dura mater layer (610) (or dura mater), CSF layer (620), blood vessel (630), gray matter (640), white matter (650), diffuse or brain It can be composed of a portion of the brain that contains fibers (660) and a tumor target (670). The learning component (230) can be customized by training to the medical procedure of interest as needed. For example, the learning component (230) may include all or part of these layers, such as the dura mater (610), white matter (650) tumor target (670).

In one embodiment, the skull layer (220) is included as a member of the learning component (230). The skull layer (220) described herein is formed from a bone-type material. When the bone material of the skull layer (220) is penetrated, bone tissue is simulated. This layer (220) is therefore intended to simulate a surgical resection. Thus, the skull material (220) of the skull part mimics the bone tissue that has penetrated or passed through. In the embodiments described herein, the medical procedure is performed through a portion of the skull simulated by the skull (600). In order for the skull portion (220) of the phantom to mimic bone tissue, the material of the skull portion (220) needs to be satisfied by the properties shown in Table 5.

Table 5: Characteristics that mimic the skull

In such embodiments, the skull material mimics the “feel” and the resistance of bone tissue, especially when being drilled. For example, a bone tissue mimic can be formed from a patterned and patterned ABS resin that resembles skull tissue. ABS is an acrylonitrile, terpolymer of butadiene and styrene, and a typical composition has half the split balance between butadiene and acrylonitrile. The advantage of using ABS material is the option of considerable composition change. The properties described in Table 5 can be achieved by adjusting the division of the ABS resin. Many blends with other materials such as polyvinyl chloride, polycarbonate and polysulfone may also be used. The acrylonitrile butadiene styrene material can be processed by any of the standard thermoplastic processing methods.

In addition, to more accurately mimic the skull (220), the skull layer (220) may have a thickness similar to that of a mammalian skull. In one embodiment, the skull layer (220) has a thickness that is close to the area of the penetrating brain skull, particularly for performing medical procedures. Thus, the skull portion of the learning model can have a total thickness in the range of about 5 to 10 millimeters.

However, depending on the medical procedure being trained, the learning model need not include the skull layer (220). Specifically, in some medical procedures, the medical procedure is directed to a structure underlying the dura mater layer (610). In this case, the emulation of the skull layer (220) is not important. Thus, the skull portion (600) is not required in the learning model. Further, as shown in FIG. 6, in some embodiments, the dura mater layer (610) may be provided under the skull portion (220). The dura mater layer (610) may be located adjacent to the innermost surface of the skull portion (220). In other words, the dura mater layer (610) is below the skull (600). The dura mater layer (610) material may be composed of materials that can simulate dura mater tissue when applying surgical instruments or when imaged.

Thus, the material of the dura mater layer (610) visually mimics the dura mater tissue when infiltrated, stitched, or passed, or is imaged with MR, CT, OCT, US, and / or PET If you mimic the dural tissue. Thus, in embodiments, as described above, the dural material mimics the “feel” and resistance of the dural tissue when cut with a scalpel or surgical scissors. In some embodiments, the dura mater layer (610) simulates non-absorbability and fluid tightness by dural tissue. In this way, a watertight housing for the fluid around the brain can be created to prevent the absorption of the CSF liquid used in the learning model (230).

For example, in some embodiments, the material of the dura mater layer (610) may be composed of urethane or silicone brushed fibers. Silicone or urethane may be used to mimic the biomechanical properties of the dura mater layer (610), but opaque silicone or urethane is used to obscure the brain and the brain groove below. It would be beneficial to do. It would also be beneficial to select silicon or urethane that envelops the shape of the sulcus.

Also, the biomechanical properties of the dura mater layer (610) can be mimicked with a layer having a thickness close to the dura mater beneath the skull. In some embodiments, the dura mater layer (610) has a thickness that approximates the dura mater beneath the medial region of the penetrating brain skull for performance of the trained medical procedure. For example, in one embodiment, the dural layer (610) has a thickness of about 1 millimeter or less. Typically, the human dura mater layer has a thickness between about 0.5 and about 0.8 millimeters.

Also, as shown in FIG. 6, in some embodiments, a vascular layer (630) may be included under the dura mater (610). The vascular layer (630) may be adjacent to the outermost surface of the brain. The biomechanical properties of a blood vessel may be any material that simulates vascular tissue when using surgical instruments or when imaged. It also visually mimics vascular tissue when (630) vascular material is stitched or invaded, and when vascular tissue is imaged with MR, CT, OCT, US, and / or PET To imitate. Thus, in the above-described embodiments, the vascular material mimics the “feel” and dural tissue resistance, particularly when cut with a scalpel or scissors. For example, in some embodiments, the material of the vascular layer (630) may be composed of a mixture of silicone material or polyvinyl alcohol cryogel (PVA-C). This material is suitable for generating appropriate MR and CT images to mimic biomechanical properties. Biomechanical properties are mimicked by using controlled cooling and heating cycles and properly controlling the stiffness of the material. Pigmentation may be used to apply a real color to the vascular layer (630).

The vascular layer (630) may have a tubular shape having a diameter similar to that of an intracranial blood vessel. In some embodiments, the vascular layer (630) may be hollow, for example, to pass a fluid that mimics blood. In one embodiment, the vascular layer (630) has a thickness between about 0.2-3 millimeters. The typical thickness of the human brain is about 1 millimeter, and the heat close to this is ideal. Further, as shown in FIG. 6, in some embodiments, the CSF layer (620) may be provided below the dura mater layer (610).

The CSF layer (620) probably surrounds the vascular layer (630) and is between the water-tight dura layer (610) and the non-liquid-absorbing brain layer (including the gray matter layer (640) and the white matter layer (650)) If a ventricle is provided, it may be inside. The CSF fluid in the CSF layer (620) may be composed of any fluid that can mimic CSF when imaging a learning component. Thus, visually CSF fluid mimics CSF, or even imaging methods such as MR, CT, OCT, US, PET, mimic CSF. In the above embodiment, the CSF material in the CSF layer (620) mimics the “feel” and dural tissue resistance, especially when cut with a scalpel or scissors. For example, in some embodiments, the CSF liquid mimic may be composed of mineral oil or saline. The above CSF liquid mimics primarily simulate the biomechanical properties of the brain. In one embodiment, the liquid is used by hydrating the fibrous structure in the brain layer including the gray matter layer (640), the white matter layer (650).

The dura mater layer (610) may also surround an amount of CSF in the mammalian brain. In one embodiment, the CSF section (620) has an average volume of between about 100 to 200 milliliters and about 150 milliliters.

Furthermore, as shown in FIGS. 6 and 7, the brain layer may be provided below the dura mater layer and the skull. When both the dura mater layer and the brain layer are provided, the brain layer may be adjacent to the dura mater layer. In other words, the dura mater layer (610) is under the skull part and the brain layer is under the dura mater layer (610). Therefore, the dura mater layer (610) is sandwiched between the skull layer and the brain layer.

In some embodiments, the brain layer is composed of materials that mimic brain tissue, such as a gray matter layer (640) and a white matter layer (650). For example, the material mimics brain features when penetrated or imaged with MR, CT, OCT, US, and / or PET. As mentioned above, this brain layer is divided into gray matter (640) and white matter (650), and even when penetrated, perforated in the brain, or imaged, Imitate. After cutting the dura mater, the medical procedure may pass through a portion of the brain layer and insert and pass a surgical instrument. For example, a trocar, catheter, drain port, obturator, Myriad® may be included. In such a case, the mimic of brain layer material may be brain tissue having a composition that responds to the device. For example, a material that prevents brain tissue from clogging Myriad®.

Thus, brain layer material mimics the “feel” and bone tissue resistance when penetrated. However, the specific nature of gray matter (640) and white matter (650) depends on the patient's disease state or the identification of the procedure for training. Thus, gray matter (640) and white matter (650) mimetics can be specifically selected to “feel” resistance and respond to the patient's medical situation or according to the trained medical procedure. .

Thus, the brain layer mimicking material may be composed of any material that can simulate brain tissue. For example, in some embodiments, the brain layer mimetic can be composed of polyurethane MCG-1 or PVA-C material. In one embodiment, the brain layer mimic is composed of a polyurethane material mixed with glass bubbles or mineral oil, etc., to achieve the desired consistency of the brain material.

In one embodiment, the brain layer material is composed of a mixture of polyurethane and glass bubbles. In order to mimic the tear strength and tensile properties of brain tissue, glass bubbles can be incorporated so as not to exceed 5% of the total volume. In other embodiments, the brain material mimic consists of a mixture of water and 6% PVA-C in one freeze-thaw cycle.

In some embodiments, the brain mimicking material may have a thickness, size, and anatomically correct sulci and ventricles that resemble brain tissue that may be encountered in performing a medical procedure being trained. . As indicated, in some medical procedures, the medical procedure is directed to the brain or structures that reside within the brain. Thus, the thickness of the brain mimetic material is selected to simulate the location in the brain or the location of the structure to which the medical procedure is directed.

Also, as shown in FIG. 6, in some embodiments, fiber bundles or brain tracks (660) may be embedded within the brain material layer mimic material. These fiber tracts (660) are for mimicking fibers in the brain (eg, fiber tracts in white matter). A fiber bundle (660) is placed in the brain phantom to emulate white matter tracts in brain tissue. The fiber bundle (660) may be composed of any substance having the same imaging characteristics of white matter fibers when imaged by MR, CT, OCT, US, PET, or the like. For example, the fiber bundle (660) mimics the diffusion and mechanical properties of white matter fibers when imaged with DWI and / or DTI, or when cut with a surgical instrument. Thus, the white matter fibers (660) of the fiber bundle mimic real white matter fibers both visually, when imaged, penetrated, sewn, or passed. Thus, in embodiments, as described above, the diffusion fiber (660) mimics the “feel” and dural tissue resistance when cut with a scalpel. In order to diffuse through water molecules, the diffusion fiber (660) is further formed into a channel. The result of this structured diffusion produces a diffusion tensor image (DTI), which is similar to the DTI of living organs such as the brain and heart. In some embodiments, the diffusion fiber (660) is a fiber configured into a sheath or cylinder. For example, plastic tube or polyester, nylon, sheath polypropylene or Dyneema fiber packed in heat shrink. In another embodiment, the fibers (660) may be embedded directly within the white matter mimic material (650). The material that mimics the surrounding brain provides a liquid that hydrates and diffuses the fibers.

The diffusion fiber (660) may have a tubular shape having a diameter close to that of the white matter tract in the brain. In some embodiments, the diffusion fibers (660) are threaded through the mimicking brain, exposing the surrounding CSF fluid mimic layer (620) and protruding from the hydrated brain material. This CSF fluid layer (620) diffuses through the tube, imparts hydration, and the effect is visible in the acquired image. The mimicking diffusion fiber (660) provides an enhanced training experience as surgeons are careful during training to avoid damaging the diffusion fiber.

Also, as shown in FIG. 6, depending on the medical procedure, in some embodiments of the learning model, the subject may be provided under the skull layer and within the brain layer material, below the dura mater layer. However, the specific location of the target under the skull can vary depending on the target and the medical procedure being directed at the target.

In general, the target simulates or mimics a particular structure embedded in the brain layer material that is the focus of the medical procedure. The particular structure or focus of the medical procedure may be an abnormal anatomical structure, blood clot, lesion, structure, a pathological condition freely determined by the physician.

In one embodiment, the particular structure to which the medical procedure is directed is the target tumor (670). The target tumor (670) may be composed of any material that can simulate tumor tissue when imaged or cut with a surgical instrument.

Thus, the target tumor (670) material visually mimics tumor tissue, or mimics tumor tissue with imaging methods such as MR, CT, OCT, US, PET. Thus, in the embodiment described above, the target tumor (670) material mimics the “feel” and dural tissue resistance when cut with a scalpel or Myriad®. For example, in some embodiments, the target tumor (670) material may be composed of a hydrocolloid material, a mixture of rubber and glass, a mixture of PVA-C, or the like. These materials may be doped with a contrast agent to simulate the imaging properties of tumor tissue. Typical examples of contrast agents include fluoride, chloride, or sulfate. Non-limiting examples include chromium fluoride, gadolinium chloride, copper sulfate, barium sulfate, manganese chloride. In addition, agarose may be included.

Thus, the simulated tumor (670) is suitable for mimicking biomechanical properties and generating images resembling tumor regions in living tissue. In embodiments, the target tumor (670) may be tumor colored to make it appear alive.

As shown in FIG. 6, in one embodiment, the target (eg, tumor (670), but not limited to) may be placed on the innermost surface of the cerebral sulcus (shown clearly in FIG. 7). like). In this example, the brain layer is provided below the dura mater layer (610), and the brain layer is sandwiched between the dura mater layer (610) and the tumor target (670) to simulate abnormal structures. Yes. Thus, the brain layer or part thereof needs to penetrate to gain access to the tumor target (670). The specific location of the tumor target (670) in or below the brain layer is selected to mimic the location of the tumor in the human brain.

The imaging and biomechanical brain phantom is configured to have a dedicated site under the skull layer (220). The size of the site is consistent with the known type of tumor. The brain phantom includes various parts that can be removed to insert a target tumor (670) at a location under a preselected skull layer (220). For example, the skull (220), dura mater (610), CSF (620), blood vessel (630), gray matter (640), white matter (650) diffusing fiber (660), etc. may be configured in a Lego fashion. The brain phantom kit disclosed herein may include tumor targets (670) of different sizes and shapes to train multiple tumor sites and multiple tumor types. This is also for phantoms that mimic different sized head phantoms or patients with different senility.

In addition, one or both of the imaging and biomechanical phantoms may place the sensor within an anatomical mimic (but not limited to) to aid navigation. The sensor may encode for a pre-prepared location in the brain phantom.

As mentioned above, using a port-based method via the sulcus deeply trained in various invasive surgical procedures to produce a realistic brain phantom with biomechanical properties Must be life-sized with sulcus.

A typical method of manufacturing a single-brain phantom containing deep sulcus is to image the human brain by MRI, and to emulate the acquired image with anatomically accurate deep sulcus using 3D printing Is included. When a brain model is generated, a flexible mold material is applied to the outer surface of the model, and after setting to form a brain mold, the model is removed from the brain mold. The brain mold is placed in a rigid shell to prevent swelling. The mold is filled with a brain material mimicking liquid precursor. Depending on the ultimate purpose of the particular phantom being manufactured, one or more brain mimicking materials may be implanted, such as the dura mater layer, the vascular layer, and the brain material track. The liquid precursor is then induced to form an integral anatomically accurate brain phantom and deep sulcus, and after the liquid precursor is set, the brain template is released from the brain mold.

The gyrus and sulcus may be manufactured with properties that approximate elasticity, shear modulus, tensile strength, or non-linear elasticity to mammalian sulci.

Since the MR images used to create the model were taken from the patient to be manipulated, the sulcus closely resembles the patient's morphology. Although non-patient specific or general brain phantoms may be manufactured for general training procedures, the advantage of using a brain phantom that matches the patient is that the practitioner closely You can practice in the state of.

An exemplary shape of the brain component of the learning component is shown in FIG. 7 as described above, showing the topography outside the brain phantom. The shape is such that the sulcus and the two lobes are accurately represented. An example of manufacturing a learning model is shown in FIGS. 8A and 8B. In this figure, a brain section (800) (with fiducial or reference marker (830)) wrapped in a dura mater member (810) located on a foundation component (820) for surgical navigation and image alignment. Show.

FIG. 9 shows a learning model or phantom by MR imaging as in FIGS. 8A and 8B. It was constructed using polyurethane material as an object that mimics the brain. As is apparent from the image, the surface profile (920), fiducial or reference (910) and the implanted tumor (900) are clearly displayed in the acquired image.

A CT image of the same training model is shown in FIG. 10 and shown in FIG. 11 as a reconstructed three-dimensional image. These figures show the brain tissue (1000) seen in Figures 10 and 11, the location of the tumor (1010), the gray matter surface (1110), and the location of the fiducial or fiducial marker. A reference point (1100) in an image acquired using multiple imaging techniques is used in different images and image guided navigation during the aforementioned surgical procedure to facilitate subsequent registration.

The tumor target may have any shape, configuration and dimensions suitable for mimicking the structure underlying the patient's skull that is the training focus of the medical procedure being simulated or mimicked. The size range can be, for example, from 1 millimeter to 3 centimeters, with consistency ranging from gelatinous to hard. In one embodiment, the tumor is made up to 1 centimeter in size from a hydrocolloid material with a concentration of 0.2% copper sulfate as a contrast agent. In another embodiment, rubber glass may be used as a tumor target. The ratio of rubber glass to slacker should not be made up to a maximum of 1: 4.
Reference: http://www.smooth-on.com/tb/files/Slacker_Tactile_Mutator.pdf

In an embodiment, the learning model or phantom may comprise simulated skin. Specifically, the skin layer may be provided on at least the outer surface of the skull portion. That is, the skin layer covers the skull portion (230). In some embodiments, in addition to covering the skull (230) including the outer surface of the learning component, the skin layer may cover all or a portion of the outer surface of the head component. Thus, the head member may include a skin layer, for example, to provide a more realistic simulation of a medical procedure.

The skin layer is composed of a skin layer material that, when infiltrated, mimics skin tissue. Thus, the skin layer material mimics the actual skin tissue when invaded or penetrated or passed.

In the embodiments described herein, prior to penetrating the skull, the medical procedure may further require skin penetration to provide access to the skull. At this time, the skin is typically cut or incised. Thus, in such embodiments, the material of the epidermis layer mimics the “feel” and skin tissue resistance when cut or incised.

The skin layer mimetic may be composed of any material capable of simulating skin tissue as described. For example, in some embodiments, the skin layer mimetic material is comprised of silicone rubber or flexible silicone elastomer.
This material is intended to simulate the biomechanics and imaging properties of the epidermal layer. Furthermore, the epidermis material may allow registration of the surface and / or face when imaged by MR, CT, US, and / or PET. In one embodiment, the skin layer material is comprised of a platinum curable silicone rubber (dragon skin) that can be colored with a skin color dye. Dragon Skin is a trademark of Smooth On Inc. This is suitable for mimicking the biomechanical and visual properties of the skin.

The skin layer may also have a thickness similar to the skin of a human head. In some embodiments, the epidermal layer has a thickness close to the skin covering the area of the penetrating brain skull of the medical procedure being trained to practice. In an embodiment, the skin layer has a thickness of about 2 millimeters.

In one embodiment of this learning model, the imaging phantom and the biomechanical phantom are configured independently, but correlate formally with each other.
In other words, the imaging phantom and the biomechanical phantom are anatomically similar and anatomically similar. Therefore, the imaging phantom can be used by imaging techniques such as MR, CT, OCT, US, and PET. These images are registered in a biomechanical phantom and can be used for navigation to train surgical procedures. In other words, the imaging phantom and the biomechanical phantom both embody the features of the training model, but the imaging phantom specifically targets the imaging characteristics and correlates directly with the biomechanical phantom. The biomechanical phantom mimics the haptic and tensile properties associated with various layers, for example within the learning component, while embodying the biomechanical and physical properties of the phantom.

The two correlated phantoms described above may be made up of three or more. The third and subsequent phantoms can be configured for different imaging modalities. In one such embodiment, the quality assurance / control phantom is configured as shown in FIG. These are phantoms that can generate a known and consistent diffusion tensor image (DTI) from a phantom with a diffusion bundle, and can be deformed or not. This is illustrated in FIG. The DTI output generated by the imaging and surgical practitioner (1220) is included in the acquired DTI reference image (1210) at the time of phantom construction for practice until the DTI when the phantom was manufactured closely matched Good. In other words, the phantom and its associated DTI are stored on a CD or other storage device and shipped together to the end user as a brain phantom kit. Companies that produce brain phantoms may also maintain DTI anywhere as long as brain phantom users are available online.

Imaging parameters are also provided along with the DTI to allow the practitioner to reproduce all imaging parameters. The quality control phantom may include a test number, for example, an optimal pulse sequence that is recorded and imaged. With a practitioner's scanner, they can optimize the pulse sequence for the practitioner's scanner by knowing the criteria that the diffusion sequence of the song and reproducing the quality control DTI sequence, for example, the optimal DTI scan A diffusion fiber mimic can be used in the image.

A software package containing the appropriate algorithm may be used by the physician to perform the analysis. For example, the practitioner scans the phantom, analyzes the acquired image for analytical quality with software, and performs a comparison with a factory-generated reference image.

The software package provides feedback to the physician, for example, regarding the resolution, the feedback may be "Resolution is too low to see the image clearly due to noise. Set the layer thickness to X or higher." Alternatively, if there is a research site, the quality control phantom can be used to develop a new pulse sequence based on the quality control DTI sequence. The software package may also include appropriate algorithms programmed to analyze patient images for quality. For example, when an operator or technician performs a scan, the software includes an algorithm that detects motion that reduces the quality of the image and provides attention to repeat the scan if an artifact occurs. If the artifact doesn't go away, the operator / technologist has a chance to try and scan the quality control phantom to solve the problem.

Also, since the pulse sequence is evolving, the software can be updated to reflect it. For example, with the continuous improvement of MRI hardware, the optimal DTI scan is not enough next year.

The development of such optimal imaging parameters (eg MR pulse sequence) is guided by the development of a scoring system (1230) that can be implemented as software or dedicated hardware by a practitioner's learning phantom. The scoring system (1230) compares the MR image (1220) generated by the practitioner training with the reference image (1210) acquired at the time of manufacture of the phantom as a standard. The score parameters may include images related to the development of the optimal DTI output. Such parameters are not limited to resolution, scan time, contrast, signal-to-noise ratio, accurate representation of fiber bundle direction via DTI, etc., acquired image dimensions, and the like. Therefore, the imaging phantom teaches how to interview clinical DTI information and MR images to safely excise the tumor target from the biomechanical phantom.

The above-mentioned DTI phantom qualified with optimal acquired data parameters need not be anatomically uniform. Alternatively, it may be a fixed geometric shape such as a sphere or cylinder. Thus, the entire set or kit of learning phantoms may include a biomechanical phantom such as the brain, an imaging phantom such as the brain, and a geometrically shaped third rigid phantom that optimizes MR data collection parameters. Some of the phantom hardware features that optimize MRI collection are shown in Table 6. These functions can be compared with previously established optimal values. Thus, the latter phantom can be used to modify the acquisition protocol and perform root cause analysis if an MR device failure is suspected.

Table 6: Prominent features of phantoms that optimize MR data collection

Some of the parameters were analyzed using the latter phantom and their roles are shown in Table 7. These parameters are intended to reduce the need for repeated scans of diagnostic, post-operative and MRI scans with insufficient data quality or pre-operative scans. The analysis result can automatically suggest a fault in the data acquisition process and suggest a method for improving the scan.

Table 7: Analytical parameters for optimizing MR data collection parameters using MR phantoms

The mammalian (human or animal) brain and head models disclosed herein can be used in a wide variety of applications, including, for example, instrument and system calibration, simulation, training, demonstration, education, and / or research. Can be used. In some example applications, embodiments provided herein are for simulation of medical procedures such as brain tumor resection, deep brain stimulator deployment, clot removal, craniotomy, and shunt installation. Can be used for Furthermore, the procedure is guided by MR, DWI, CT, OCT, PET and ultrasound by the imaging modality.

As mentioned above, it lists various materials that can be used for the head and brain phantoms. The following provides examples of imaging and biomechanical phantoms.

Example Imaging Phantom and Manufacturing Method
The images obtained by MRI were used for 3D printing of deep sulcus and brain anatomically accurate shapes emulating the human brain. Although MRI was used in this example, it may also include images obtained using other modalities, such as but not limited to MRI, CT, PET, etc. The brain was then cast by painting it with a flexible material such as silicon, plastic, rubber, or latex. This mold was then released from the printed brain by scoring a large X on the underside of the brain, allowing the lower surface of the mold to be folded back to release the printed brain inside. The flexible mold can then be used to mold an anatomically correct brain in one piece with a deep cerebral groove that can then be released from the mold via a crosshair on the underside. The brain material is molded with agar, gelatin, polyurethane, soy gel, or 1-15% PVA formulation using 1-8 freeze / thaw cycles. During the molding process, the brain mold is placed in a tough outer shell that prevents the mold from expanding during the process. The PVA hydrogel was constructed by emulsifying 4% PVA and 0.1% biocide in water. This mixture was poured into a mold and made using two freeze / thaw cycles to achieve the proper biomechanical properties of the brain. Figure 13 shows a photograph produced by the brain phantom in this way.

As described above, the brain phantom may include a target for excision of, for example, a tumor target, a thrombus, or an abnormal anatomical feature. These targets are designed to emulate the biomechanical and imaging (MRI, CT, US) characteristics of a particular target or targets. For example, in the case of brain tumors, imitation of ICH / abscess, metastatic / cavernoma, high grade glioma, low grade glioma is provided. These targets are molded from 0.1 centimeters to 5 centimeters by forming a mold with a size close to the lesion. The mold may be irregularly shaped similar to a spherical or real brain lesion. These templates may contain leads that help connect tumors in the brain. For example, one target can model a tumor that is 2 to 4 cm from the surface of the sulcus in the left frontal part of the brain and is 3 cm in size. These tumors are made with PVA (concentration 1-15%) dissolved in water and formed through 1-8 freeze / thaw cycles to achieve biomechanical and imaging properties. The target is supported by intersecting wires and is located in the brain phantom. This wire places the target where it can be reproduced. The tumor target (s) are placed on the wire before injecting the brain preparation. After the mold is set, the wire is withdrawn from the mold and the target remains inside.

The imaging phantom is configured with the same PVA-C concentration as the ablation phantom. However, the imaging phantom is non-disposable and is surrounded by a skull. This imaging phantom may not be present in the ablation (biomechanics) phantom and may include other functions that do not destroy the relationship between the two phantoms. For example, a target in the imaging brain phantom correlates to a target in the ablation or biomechanical phantom. However, imaging phantoms are manufactured to distinguish gray matter white matter and include the cerebellum, ventricles, CSF, and diffusing fibers. The gray matter layer may be composed of one or more freeze / thaw cycles and a% 2% -8 PVA-C hydrogel mixture, overmolded over the white matter layer, T1, T2 and T2 (* ) Dope with appropriate concentration of contrast to achieve human brain properties. This is accomplished by mixing the appropriate chemicals with the materials in the PVA formulation. As described above, these contrast agents may be fluorides, chlorides, sulfates, and the like. Non-limiting examples include chromium, fluoride, gadolinium chloride, copper sulfate, barium sulfate, manganese chloride. In addition, agarose may be used.

Materials that mimic diffusing fibers or fiber bundles can be constructed by immersing wicking strands of materials such as yarns, twists, fabrics, or ropes in a hydrogel. Phantoms are produced by replicating various anisotropy (FA) and apparent diffusion coefficient (ADC) characteristics. Anisotropy (FA) is a scalar constant with a value between zero and one. Zero means isotropic and 1 means strong diffusion only in one direction. Apparent diffusion coefficient (ADC) indicates how diffusible the fiber is, with the larger value showing the higher value and the lower value showing the lower value.

Within the diffusion phantom, ADC and FA values are achieved by adjusting fiber parameters such as fiber quantity, fiber material, fiber diameter (0.001-5 mm). The fibrous structure can include braided or bundled structures. The fiber material is organic and / or synthetic such as nylon, cotton, polyester, polyethylene, animal hair, wool, silk, Teflon (registered trademark), bamboo, rayon, glass fiber, silica, wire for microfiber, etc. Fibers can be included. These fibers may be covered with a material such as wax that determines the FA and ADC properties of diffusion.

These strands may be formed individually or in bundles together. Individual bundles may be less than 5 millimeters in diameter, or thin to approximate the diameter of the fiber tract in the brain. These fibers can be composed of materials such as wood, bamboo, silk, polypropylene, or nylon. The hydrogel hydrates and the strands provide uptake and fiber orientation. These fibers can be configured to emulate a pattern of diffusing fibers or tracks in the brain.

Alternatively, these fibers can be placed in a quality control phantom to develop a diffusion pulse sequence or to assess the quality of imaging. The diffusion tensor image phantom was constructed from a 4 mm diameter nylon kahn mantle rope suspended in a lattice in a plastic container. The container was formed from 8% PVA hydrogel with two freeze-thaw cycles. A diffusion weighted image (DWI) is acquired using this phantom and is shown in FIG. That grid was formed by mimicking diffusion fibers in the phantom. Alternatively, a material that mimics diffusing fibers or fiber bundles can be constructed by dipping strands of wicking material in a tube filled with water and sealed. For example, a nylon kermantle rope having a diameter of 4 millimeters is passed through a Teflon tube having a diameter of 6 millimeters that is filled with water and sealed with a heat seal resin. These fibers can replicate the diffusion fibers or diffusion tracks in the brain or alternatively to calibrate or modify MRI and diffusion-weighted imaging scans, for example when immersed in imaging liquid as PVA hydrogels .

The above disclosure describes a phantom with imaging and biomechanical characteristics (a single phantom or two phantoms, one optimized for use as an imaging phantom and the other as biomechanical. Although the same principles and methods can produce phantoms with anatomical parts such as organs, joints, spines, etc. Based on the same principles as a brain phantom or brain simulator, the mimetic is selected as a material that mimics the imaging properties and the actual anatomical and biomechanical properties.

Each of the specific embodiments described above is an exemplification, and needless to say, various modifications and alternatives can be made. Furthermore, the claims are not limited to the specific forms disclosed herein, but are intended to include all modifications, equivalents, and alternatives that do not depart from the spirit and scope of the present invention.

Claims (76)

Complementary head phantom kit,
a) a first imaging head phantom comprising an anatomical mimic of a mammalian brain composed of a material that is imageable by one or more imaging techniques;
b) at least a second biomechanical head phantom comprising an anatomical mimic of a mammalian brain composed of a material imageable by one or more imaging techniques;
c) At least the second biomechanical phantom described above and the first imaging head phantom are registered together, and at least one acquired using at least one imaging technique with the first imaging head phantom The image is registered with a second biomechanical head phantom, and the second biomechanical head phantom of the second biomechanical head phantom is registered during a surgical training procedure according to one or more acquired image features from the imaging phantom. In order to provide navigation, a biomechanical head phantom function is provided that correlates geometrically with corresponding functions. The first imaging phantom and the at least one second biomechanical head phantom include a tray member, a head phantom member and a brain phantom member, and the head phantom member has a face phantom member coupled to a bowl member. The bowl member is sized and shaped to accept the brain phantom member, and the head phantom member includes a skull member having an appropriate size and shape to cover the brain phantom member, and the tray has a head The complementary head phantom kit of claim 1, comprising a system configured to release a partial phantom. The supplemental head phantom kit according to claim 1 or 2, comprising any one or combination of distinct structural features located outside of the imaging phantom and the biomechanical phantom. The supplemental head phantom kit of claim 1, wherein the first imaging phantom and the at least second biomechanical head phantom are substantially physically identical in size and form to each other. The imaging phantom and at least the second biomechanical head phantom include anatomical mimics (eg skull mimic layers, dura mater mimic layers, cerebrospinal fluid mimic layers, vascular mimic layers, gray matter mimetics and white matter mimetics) Brain slice mimics, diffusion fiber mimics, etc.), and all mentioned mimetics generally have imitations that have a size, shape and position relative to each other to form the human brain. The supplemental head phantom kit of claim 1, comprising: The mammalian brain mimic comprises a plurality of tumor mimics, and the tumor mimic mimics a single tumor if there is only one brain tumor mimic, if necessary, and one or more brain tumor mimics The supplemental head phantom kit of claim 5, comprising mimicking one or more tumors. Claims characterized by at least a second biomechanical head phantom comprising a material that mimics the `` feel '' and resistance of mammalian skin when a crust mimic layer covering the skull mimic layer is penetrated by cutting or incision. 5. A supplemental head phantom kit according to 5. The supplemental head phantom kit according to claim 7, characterized by a skin mimicking layer composed of either silicone rubber or flexible silicone elastomer. The supplemental head phantom kit according to claim 7, characterized by a skin mimicking layer composed of platinum-cured silicone rubber colored with skin-colored dyes or pigments. The supplemental head phantom kit of claim 2, wherein each of said imaging phantom and biomechanical phantom includes one or more reference points optimally arranged for image registration and / or face registration . One or more fiducial marks are attached to A) one or more positions on the tray, or B) one or more positions on the head phantom, or C) any combination. The supplemental head phantom kit of claim 10. 8. A supplemental head phantom kit according to claim 7, wherein one or more reference points are provided that are arranged to strategically enable image registration and / or facial registration of the skin mimicking layer. . The supplemental head phantom kit of claim 7, wherein the skin mimicking layer described above has a thickness of about 2 millimeters. 6. The supplemental head phantom kit of claim 5, wherein the cerebrospinal fluid mimicking layer comprises a fluid that mimics the “feel” and cerebrospinal fluid viscosity as the surgical instrument is passed. 15. The supplemental head phantom kit of claim 14, comprising the liquid in any one or a combination of mineral oil and saline. 6. The supplemental head phantom kit of claim 5, comprising a cerebrospinal fluid mimicking layer having a volume of about 100-200 milliliters. The supplemental head phantom kit of claim 5, comprising a dura mater mimic layer having a thickness in the range of about 0.5 to 0.8 millimeters. 6. The supplemental head phantom kit of claim 5, comprising a vascular mimic layer underlying the dura mater mimic layer but sandwiched between the dura mater mimic layer and the brain partial mimic layer. When a surgical instrument comes into contact with biomechanics or is imaged,
6. The supplemental head phantom kit of claim 5, comprising the vascular mimetic layer that mimics vascular tissue. 20. The supplemental head phantom kit of claim 19, comprising the vascular mimetic layer made from a mixture of any silicone material and polyvinyl alcohol cryogel (PVA-C). 20. The supplemental head phantom kit of claim 19, comprising the vascular mimetic layer having a diameter in the range of about 0.2-3 millimeters. 6. A supplemental head phantom kit according to claim 5, comprising a brain slice mimic consisting of a mixture of any one or a combination of materials of polyurethane MCG-1 and PVA-C. Polyurethane MCG-1 and PVA-C materials and additives are mixed, the additive consists of a combination of glass foam and mineral oil, and the amount of said additive is an appropriate amount to give a selected consistency 23. A supplemental head phantom kit according to claim 22, comprising a brain section mimic in addition to. The brain slice mimetic is composed of a mixture of polyurethane and glass bubbles, and includes that the glass bubbles do not exceed 5% of the total volume to mimic the tear strength and tensile properties of brain tissue. Supplementary head phantom kit according to 23. 24. The supplemental head phantom kit of claim 23, comprising a brain slice mimic that is subjected to two freeze-thaw cycles and is composed of a mixture of water and about 4% PVA-C material. 23. A supplemental head phantom kit according to claim 22, comprising the brain slice mimic having a thickness, dimensions, and anatomically accurate sulcus and ventricles that approximate human brain tissue. 6. The supplemental head phantom kit according to claim 5, characterized in a dura mater mimic composed of urethane and silicone brushed fibers. Claim wherein the dura mimetic layer closely covers the brain mimic layer and is made so that no more than 1 millimeter is between the dura mimetic layer and the brain mimic layer while closest to the gyrus mimic and dura mimic Supplementary head phantom kit according to item 5. 29. A supplemental head phantom kit according to claim 28, comprising the mimic dural layer made from a waterproof material. The supplemental head phantom kit according to claim 5, characterized in that the skull mimetic layer is made of a material that mimics bone tissue. 32. The supplemental head phantom kit of claim 30, comprising a bone tissue mimic made from acrylonitrile butadiene styrene (ABS) material. 6. The supplemental head phantom kit of claim 5, comprising the diffusion fiber mimic being embedded in the brain mimic and the fiber bundle being disposed within the brain mimic to emulate a white matter tract. . Made of a wicking material with a diameter of less than about 4mm, close to the diameter of the white matter fiber tract of the human brain, the fiber bundles are mimicking the brain to replicate the white matter fiber tract pattern of the brain mimicking part when hydrated 35. The supplemental head phantom kit of claim 32, which is threaded. The supplementary claim according to claim 32, wherein the fiber bundle is composed of any of polyester, nylon, polypropylene, dyneema and other fibers filled in a plastic tube, the fiber bundle being configured to provide a water channel. Head phantom kit. 35. A supplemental head phantom kit according to claim 34, characterized by fiber bundles having a tubular shape of approximate diameter in the white matter tract in a human brain section. 35. The supplemental head phantom kit of claim 34, wherein the fiber bundles are passed through the brain mimicking portion to project from the selected location into the cerebrospinal fluid mimicking layer, where they are exposed and hydrated. The supplemental head phantom kit of claim 6 having one or more tumor mimics composed of any of a hydrocolloid material, a rubber and glass mixture, and a mixture of PVA-C. 38. A supplemental head phantom kit according to claim 37, comprising a tumor mimetic doped with a contrast agent to simulate the imaging properties of the tumor tissue. 38. A supplemental head phantom kit according to claim 37, characterized by the tumor mimetic comprising pigmentation applied to express realistic tumor coloration. 40. The supplemental head phantom kit of any one of claims 1-39, having an appropriate amount of contrast agent to adjust the properties of T1 and / or T2. 41. 41. The method of claim 40, wherein the contrast agent is any fluoride, chloride, sulfate and agarose. 42. Any of the imaging brain phantoms or biomechanical brain phantoms, including an image acquired by one or more MRIs and functions stored in a storage device accessible by a practitioner during the procedure along with imaging parameters. Supplemental head phantom kit according to one item. Manufacturing method for brain phantoms such as deep sulcus:
Acquire an image of the human brain, and use the acquired image to 3D print with an anatomically accurate model of the deep sulcus and brain that emulates the human brain, and flexibly on the outer surface of the brain model After applying the mold material and forming the brain mold, the brain mold is released from the brain model, the brain mold is placed on the hard shell, the template is submitted as a liquid precursor of the brain mimic, and the brain is A method of embedding a liquid precursor for the structural features of, forming an anatomically accurate brain phantom with deep sulcus, and releasing the brain phantom from the brain form. 44. The method of claim 43, wherein the human brain is obtained using an image of any of MRI, CT, and PET. 44. The method of claim 43, wherein the brain mimicking material is any of agar, gelatin, polyurethane, PVA-C, and soy gel. 44. The method of claim 43, wherein the brain mimetic is a composite material comprising polyurethane and additive in an amount that provides optimal consistency. 47. The method of claim 46, wherein the additive comprises one or a combination of glass bubbles, mineral oil. 44. The method of claim 43, wherein the brain mimetic is between about 1 and about 15% polyvinyl alcohol (PVA) formulation. 49. The method of claim 48, comprising subjecting the polyvinyl alcohol (PVA) formulation to about 1-8 freeze / thaw cycles to harden the brain mimic. Brain mimetics are between 4-8% polyvinyl alcohol (PVA) formulations, and the step of inducing brain mimics exposes polyvinyl alcohol (PVA) to about 1-8 freeze / thaw cycles. 49. The method of claim 48, comprising. 51. The method of filling a template with a brain mimetic comprises adding any one or combination of glass bubbles and mineral oil in an amount selected to provide tactile properties. the method of. 52. Filling a template with a brain mimetic comprises mixing with an appropriate amount of contrast agent to have T1 and / or T2 properties in the brain mimetic. Method. 53. The method of claim 52, wherein the contrast agent is any of fluoride, chloride, sulfate, or agarose. 54. The method according to any one of claims 43 to 53, wherein filling the template with a brain mimetic comprises a crossing of mixing contrast agent and biocide. Implanting one or more mimetics in a liquid precursor for one or more structural brain machines, either implanting a diffusion fiber mimic and a bundle of said diffusion fibers, and human brain tissue 54. A method according to any one of claims 43 to 53, wherein either or both of the fibers and diffusing fiber bundles are placed inside the brain to emulate an inner white matter track. 56. The method of claim 55, wherein the diffusion fiber mimic is composed of a wicking material. The method of claim 56, wherein the wicking material is one of a thread, string, cloth, or rope. 57. The method of claim 56, wherein the diffusion fiber mimic is made from any of silk, polypropylene, polyester, nylon, polypropylene, Dyneema fiber wood fibers. The method of claim 55, wherein the diffusing fiber mimic and the bundle are configured with channels to diffuse water molecules. 60. A method according to any one of claims 55 to 59, wherein the diffusion fiber mimic and the bundle (one or both) are packed in a plastic tube. After releasing a specific brain phantom from the brain type, one or more reference magnetic resonance imaging (MRI) images are acquired, and one or more reference magnetic resonance images and imaging parameters are acquired by the practitioner during training 61. A method according to any one of claims 43-60, comprising saving to a labeled storage medium associated with a particular brain phantom so that it is accessible. During training, one or more reference magnetic resonance images (MRI) images are acquired after a specific brain phantom is released from the brain type, and one or more reference diffusion tensor images (DTI) and imaging parameters are created. 61. The method of any one of claims 55-60, further comprising storing in a labeled storage medium associated with a particular brain phantom so that it can be accessed by the practitioner. One or more acquired diffusions to match one or more reference diffusion tensor images using an imaging phantom by calculating a metric that incorporates MRI parameters to generate an optimal diffusion tensor image An MR image suitable for a practitioner to generate a diffusion tensor image by training according to the method of claim 62, comprising the step of iteratively improving the tensor image and adjusting one or more parameters based on the metric. Way to get. The MRI parameter is any one or combination of resolution, scan time, contrast, signal-to-noise ratio, accurate representation of fiber bundle direction via diffusion tensor images, dimensions from acquired images. The method according to 63. A mammalian brain phantom,
Includes a simulated mammalian brain that includes a sulcus topographical structure on the outer surface, and the simulated mammalian brain images one or more structural features of the simulated mammalian brain when imaged The images taken by the technology are identifiable and have composition as one or more structural features including the gyrus and sulcus, and the whole mammalian brain phantom is one or more of the actual mammalian brain With one or more characteristics comparable to their associated biomechanical characteristics. 66. The phantom of claim 65, wherein the sulcus has one or a combination of elastic modulus, shear modulus, tensile strength or non-linear elastic properties comparable to mammalian cerebral sulci. A base, a lower head on the base, a face, and the simulated mammalian brain rests on the base behind the face and strategically registers and / or 67. A method according to any one of claims 65 to 66, comprising locating an identifier that enables registration of a face. Simulated mammalian brains include skull mimic layers, dura mater mimic layers, cerebrospinal fluid mimic layers, vascular mimic layers, brain mimics including gray matter and white matter mimetics, diffusion fiber mimics, etc 68. A method as claimed in any one of claims 65 to 67, comprising: and all the mimetics generally have a size, shape and position relative to each other to simulate the human brain. . 69. A phantom according to claim 68, wherein the simulated mammalian brain comprises a target mimic located therein. 70. The phantom of claim 69, selected to mimic a particular structure embedded in brain layer material that is the focus of the medical procedure to which the medical procedure is directed. 71. The subject mimetic comprises any normal or abnormal anatomical structure or combination, such as a blood clot, a lesion, a tumor affected by medical treatment or an abnormal and pathological structure. Phantom. 71. The phantom of claim 70, wherein the target mimetic comprises being a target tumor mimetic. When the composition of the target tumor mimetic is imaged, one or more structural features of the target tumor mimetic are recognizable and comparable to one or more biomechanical characteristics of the actual tumor The phantom according to claim 2, further comprising: 74. The phantom of claim 73, wherein the composition comprises a hydrocolloid material, a rubber and glass mixture, and a mixture doped with any of PVA-C. 75. The phantom of claim 74, wherein the composition is doped with one or more contrast agents to simulate the imaging properties of tumor tissue. To meet in a system with a programmed computer readable medium to quantify the accuracy of the ablation training procedure by a physician, the programmed instructions are the original image and ablation of the target mimic originally located in the brain phantom 68. A phantom according to any one of claims 65 to 67, comprising a method for estimating the amount of target mimic remaining, comparable to an image taken of the same volume of brain after process.